Taught course

Regulatory Affairs

Institution
Humber College Institute of Technology & Advanced Learning · Humber College Institute of Technology & Advanced Learning
Qualifications
PGCert

Entry requirements

To be eligible for admission, you must possess the following: A Bachelor of Science degree, majoring in health science, pharmacy, some area in life sciences or a related field. All applicants whose first language is not English must meet Humber’s English Language Proficiency Policy.

Months of entry

September

Course content

Humber’s Regulatory Affairs graduate certificate program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, medical device or biotechnology industries. You will gain knowledge of the regulatory system, legislation, procedures and practices which relate to the development, manufacture, quality assurance and marketing of health-related products.

The importance of internationally harmonized regulations and future trends in the industry will be examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices, good laboratory practices, good clinical practices, good documentation practices, the International Organization for Standardization (ISO), the Canadian Food and Drugs Act, the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines. Teamwork and communication skills are emphasized and you will acquire information technology skills that assist communication and data management specific to regulatory affairs.

You will become familiar with the steps necessary for product submission; how to assemble documents and statistical evidence; the complexity of product registration, negotiation and follow-up, and how these are linked to the federal government and provincial formularies.

Qualification and course duration

PGCert

full time
12 months

Course contact details

Name
International
Email
international@humber.ca